NCT00249951

Alkaline Citrate Treatment to Lower the Risk of Nephrocalcinosis in Preterm Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of Cologne · Academic / Other
• Sex: All
• Age: 5 Days – 8 Weeks
• Healthy volunteers: Not accepted

Summary

Preterm infants are at risk to develop nephrocalcinosis. Incidence numbers vary according to birth weight and gestation age. Very low birth weight infants have the highest risk index, with \~ 7-10 % of preterm infants developing nephrocalcinosis in the patient population. We, the researchers at the University of Cologne, and others found significantly decreased urinary citrate excretion (hypocitraturia) to be one of the main risk factors. Hence, we hypothesized, that prophylactic treatment with oral alkaline citrate solution (Shol's solution) would help to 1) increase urinary citrate excretion and 2) help to decrease the incidence of nephrocalcinosis.

Conditions

• Nephrocalcinosis

Interventions

Type	Name	Description
DRUG	Alkaline citrate	Prophylactic alkaline citrate medication during the first 8 weeks of life versus placebo solution to prevent nephrocalcinosis of prematurity.

Timeline

• Start date: 2005-11-01
• Primary completion: 2008-11-01
• Completion: 2008-11-01
• First posted: 2005-11-07
• Last updated: 2012-07-03

Locations

1 site across 1 country: Germany